Rifaximin - Generic Drug Details

What are the generic drug sources for rifaximin and what is the scope of patent protection?

Rifaximin is the generic ingredient in one branded drug marketed by Salix Pharms and is included in one NDA. There are twenty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rifaximin has two hundred and sixteen patent family members in forty countries.

There are fourteen drug master file entries for rifaximin. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for rifaximin

International Patents:	216
US Patents:	29
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	172
Patent Applications:	6,767
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rifaximin
What excipients (inactive ingredients) are in rifaximin?	rifaximin excipients list
DailyMed Link:	rifaximin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for rifaximin

Constraining patent/regulatory exclusivity:

8,193,196

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,193,196

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for rifaximin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tata Memorial Centre	Phase 2
Al-Azhar University	Phase 2
Xin Zeng	N/A

See all rifaximin clinical trials

Generic filers with tentative approvals for RIFAXIMIN

Applicant	Application No.	Strength	Dosage Form
		550MG	TABLET;ORAL
		550MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for rifaximin

Drug Class

Rifamycin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for rifaximin

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for RIFAXIMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIFAXAN	Tablets	rifaximin	200 mg	021361	1	2019-01-28
XIFAXAN	Tablets	rifaximin	550 mg	021361	1	2015-12-18

US Patents and Regulatory Information for rifaximin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	7,045,620		Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	7,612,199		Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	8,309,569
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	8,158,644		Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	11,779,571

Expired US Patents for rifaximin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	8,158,781
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	7,045,620
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	7,902,206
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	7,045,620
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	8,853,231

International Patents for rifaximin

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006094662
South Korea	100883216
China	102625701	Modulation of systemic exposure to rifaximin
Denmark	1676847
Brazil	PI0608073	formas polimorfas de rifaximina, processos para sua produção e uso das mesmas em composições medicinais

Rifaximin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Rifaximin

Introduction

Rifaximin, a broad-spectrum antibiotic, has been gaining significant traction in the pharmaceutical market due to its efficacy in treating various gastrointestinal disorders. Here, we delve into the market dynamics and financial trajectory of rifaximin, highlighting key drivers, constraints, and future projections.

Market Size and Forecast

The rifaximin market has been valued at USD 1.27 billion in 2023 and is projected to reach USD 4.11 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 11.7% during the forecast period of 2024-2031[1].

Key Drivers of Market Growth

Increased Prevalence of Gastrointestinal Disorders

The rising incidence of gastrointestinal disorders such as irritable bowel syndrome (IBS), Crohn’s disease, and travelers’ diarrhea has significantly driven the demand for rifaximin. The awareness around gut health and the importance of addressing gastrointestinal issues has heightened, further boosting market demand[1].

Growing R&D Activities

A surge in research and development activities is propelling the rifaximin market. Pharmaceutical companies are investing in clinical trials and studies to explore its potential benefits beyond its current uses, such as therapies for hepatic encephalopathy and other off-label indications. New formulations and combinations may emerge, expanding the overall market[1].

Rising Awareness and Acceptance

Favorable regulatory approvals across various regions have fortified the market presence of rifaximin. The approval and endorsement by health authorities like the FDA for specific indications have increased its market acceptance. Global pharmaceutical partnerships also facilitate the drug’s availability in emerging markets, creating a wider consumer base[1].

Growth in the Travel Industry

The travel industry's growth contributes to the increased incidence of travelers’ diarrhea, a condition effectively treated by rifaximin. This adds to the demand for the drug, particularly among travelers to regions with high risks of gastrointestinal infections[1].

Market Segmentation

By Application

The rifaximin market can be segmented into hospital and drug store applications. Hospitals are a significant segment due to the treatment of severe gastrointestinal conditions, while drug stores cater to outpatient prescriptions[4].

By Product

The market is segmented into 200 mg and 550 mg tablets, each serving different therapeutic needs. The 550 mg tablets are often used for more severe conditions like hepatic encephalopathy[4].

Geographical Segmentation

The market is geographically segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Each region exhibits distinct market dynamics driven by varying healthcare systems, regulatory environments, and disease prevalence rates.

• North America: Influenced by high healthcare expenditure and advanced medical infrastructure.
• Europe: Characterized by a well-established pharmaceutical market and emphasis on antibiotic stewardship.
• Asia-Pacific: Rapidly expanding due to improving healthcare infrastructure and rising awareness of gastrointestinal diseases.
• Latin America: Presents growth opportunities driven by a rising burden of liver diseases and increased healthcare access.
• Middle East and Africa: Marked by a growing need for effective antibiotics, though access to healthcare and affordability may be significant barriers[1][4].

Financial Impact and Cost Savings

Healthcare Costs

Studies have shown that rifaximin can significantly reduce healthcare costs associated with treating conditions like hepatic encephalopathy. Patients adherent to rifaximin incurred $2,891 lower total healthcare costs compared to non-adherent patients. This translates to potential cost savings of $7.5 million per year in a simulated plan of 1 million lives if 50% of patients treated with lactulose alone were switched to rifaximin[5].

Economic Benefits

A UK-based retrospective study highlighted that rifaximin significantly reduced 30-day readmissions and emergency department attendances, as well as hospital and critical care bed days. This resulted in annual savings of 1,480–3,228 GBP per patient, demonstrating socio-economic advantages, especially in limited resource settings[2].

Challenges and Constraints

Intense Market Competition

The rifaximin market faces intense competition from generic versions and other antibiotics, driving prices down and impacting profit margins for original brand manufacturers. The rise of novel therapeutic agents with better efficacy or safety profiles may also divert interest from rifaximin-based products[1].

Limited Awareness

Despite its benefits, there is still limited awareness about rifaximin in some regions, which can hinder market growth. Educational initiatives and marketing strategies are necessary to increase awareness among healthcare providers and patients[1].

Regulatory Environment

Favorable Regulatory Approvals

Regulatory approvals and endorsements by health authorities have been crucial in expanding the market for rifaximin. Streamlined regulatory processes have allowed for quicker market entry for new formulations, and global partnerships have facilitated its availability in emerging markets[1].

Future Projections and Trends

Expanding Indications

Ongoing studies and clinical trials are exploring new uses for rifaximin, such as small intestinal bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD). These expanding indications are expected to further boost the market[4].

Increasing Global Access

Improving healthcare infrastructure and rising awareness in regions like Asia-Pacific and Latin America are expected to drive market growth. However, economic factors and regional disparities in healthcare quality may temper this growth[1][4].

Key Takeaways

• The rifaximin market is projected to grow significantly due to the increasing prevalence of gastrointestinal disorders.
• Growing R&D activities and favorable regulatory approvals are key drivers of market growth.
• The market faces challenges from intense competition and limited awareness in some regions.
• Rifaximin offers significant cost savings and socio-economic benefits, particularly in treating conditions like hepatic encephalopathy.
• Expanding indications and increasing global access are expected to further boost the market.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of rifaximin by 2031? A: The rifaximin market is projected to reach USD 4.11 billion by 2031, growing at a CAGR of 11.7% during the forecast period of 2024-2031[1].

Q: What are the primary drivers of the rifaximin market? A: The primary drivers include the increasing prevalence of gastrointestinal disorders, growing R&D activities, rising awareness and acceptance, and growth in the travel industry[1].

Q: How does rifaximin impact healthcare costs? A: Rifaximin can significantly reduce healthcare costs associated with treating conditions like hepatic encephalopathy, resulting in lower hospital admissions and healthcare expenditures[5].

Q: What are the challenges faced by the rifaximin market? A: The market faces intense competition from generic versions and other antibiotics, as well as limited awareness in some regions[1].

Q: What are the future trends in the rifaximin market? A: Future trends include expanding indications for rifaximin, such as SIBO and IBD, and increasing global access due to improving healthcare infrastructure and rising awareness[4].

Cited Sources:

1. Verified Market Research - Rifaximin Market Size, Scope, Growth, Trends and Forecast.
2. EMJ Reviews - Review of Rifaximin: A Summary of the Current Evidence and Benefits Beyond Licensed Use.
3. NewsNet Media - Rifaximin Market Dynamics till 2032 | Growth Drivers, Market Constraints and Challenges.
4. Market Research Intellect - Rifaximin Market Size, Trends and Projections.
5. Analysis Group - Hospitalizations and Healthcare Costs Associated with Rifaximin Versus Lactulose Treatment Among Commercially Insured Patients with Hepatic Encephalopathy in the United States.